BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 1812154 · Received August 17, 2010

    Report

    Report Number
    2024168-2010-01688
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    July 21, 2010
    Report Date
    July 23, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, AND ACCESSORY DEVICE SUPPORT. THE PATIENT ANATOMY WAS HEAVILY CALCIFIED, WHICH LIKELY CONTRIBUTED TO THE FAILURE TO ADVANCE. FACTORS WHICH MAY CONTRIBUTE TO RESISTANCE DURING RETRACTION INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING BALLOON FOLD ISSUES, KINKS, BENDS, OBSTRUCTIONS IN THE GUIDING CATHETER LUMEN, OR DAMAGE TO THE GUIDING CATHETER. IN THIS CASE, IT IS LIKELY AN INTERACTION WITH THE LESION/ANATOMY DURING THE ATTEMPT TO CROSS THE CALCIFIED LESION MAY HAVE RESULTED IN A KINK IN THE HYPOTUBE, FURTHER CONTRIBUTING TO DIFFICULTY REMOVING THE CATHETER. FURTHER HANDLING COULD HAVE CONTRIBUTED TO THE SHAFT ULTIMATELY SEPARATING. THE REPORTED FAILURE TO ADVANCE APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE; HOWEVER, A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTY REMOVING THE CATHETER AND HYPOTUBE SEPARATION COULD NOT BE DETERMINED. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. ALL DILATATION CATHETERS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE BEFORE RELEASE. ADDITIONALLY, ALL DILATATION CATHETERS ARE 100% VISUALLY INSPECTED ONLINE FOR DAMAGE.

    Description of Event or Problem · 1

    DEVICE ISSUE: HYPOTUBE SEPARATION. TIME OF DEVICE ISSUE: DURING THE PROCEDURE. ADVERSE EVENT: NONE. IT WAS REPORTED THAT DURING THE PROCEDURE, IN THE HEAVILY CALCIFIED RIGHT CORONARY ARTERY, THE VOYAGER NC DILATATION CATHETER WAS ADVANCED, BUT COULD NOT CROSS TO THE LESION. AN ATTEMPT WAS MADE TO WITHDRAW THE CATHETER; HOWEVER, RESISTANCE WAS FELT AND THE HYPOTUBE SEPARATED 35 MM DISTAL TO THE MARKER, NEAR THE HUB AT THE Y-ADAPTER. BOTH SEPARATED PORTIONS OF THE DEVICE REMAINED ON THE GUIDE WIRE AND THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE ANATOMY. ANOTHER VOYAGER DILATATION CATHETER WAS USED TO COMPLETE DILATATION AND THERE WAS NO ADVERSE PATIENT EFFECT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER NC CORONARY DILATATION CATHETER LOX ABBOTT VASCULAR-CARDIAC THERAPIES NA 9111261

    Patients

    Seq Age Sex Outcome Treatment
    1